Product code FST
- Device name
- Light, Surgical, Fiberoptic
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4580
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | Innovasis, Inc. | 2020-06-30 |
| K141330 | ENDO-CORD | Enroxtech, Inc. | 2014-12-15 |
| K122637 | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 | Stryker Spine | 2012-11-01 |
| K113697 | EIGR SURGICAL ILLUMINATION SYSTEM | Invuity, Inc. | 2012-02-10 |
| K113330 | CABLECAP | Sensormed | 2012-01-12 |
| K102266 | ISOLED AC-POWERED LED HEADLIGHT SYSTEM | Isolux, LLC | 2010-09-24 |
| K101496 | CABLECAP MODEL: WLF, STZ, ACM | Sensormed | 2010-09-14 |
| K100388 | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS | Medical Illumination International, Inc. | 2010-06-22 |
| K100395 | HARMONY VLED SURGICAL LIGHTNING SYSTEM | STERIS Corporation | 2010-03-17 |
| K093386 | CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST | Bfw, Inc. | 2010-01-28 |
| K090070 | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM | Invuity, Inc. | 2009-04-22 |
| K083710 | RETRACTOR LITE | Thomas Surgical Instruments, Inc. | 2009-02-23 |
| K082992 | AXXION LIGHT GUIDE | Spinal Elements, Inc. | 2009-02-18 |
| K080962 | LITE WAND II | Thompson Surgical Instruments, Inc. | 2008-06-25 |
| K080367 | ZIMMER MIS LIGHT | Zimmer Spine, Inc. | 2008-02-22 |
| K071218 | PROXENON 350, MODEL 902XX | Welch Allyn, Inc. | 2007-06-14 |
| K061690 | SURGICAL HEADLIGHT | Gulf Medical Fiberoptics | 2006-09-15 |
| K053227 | LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES | Medical Illumination International, Inc. | 2006-01-13 |
| K051786 | MELIDE FIBEROPTIC LIGHT | Designs For Vision, Inc. | 2005-08-15 |
| K042034 | NUVASIVE MAXCESS LIGHT GUIDE | Nuvasive, Inc. | 2004-10-26 |
| K003577 | STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT | STERIS Corporation | 2001-01-29 |
| K000728 | MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE | Medtronic Xomed | 2000-03-21 |
| K991572 | ISOLUX SURGICAL HEADLIGHT | Isolux America | 1999-07-08 |
| K972225 | UFR FIBEROPTIC CABLE | Universal Fiberoptic Repair, Inc. | 1998-03-18 |
| K955510 | X6000D SILENT SUN LIGHT SOURCE | Products For Medicine | 1996-01-31 |
| K936048 | LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) | Cogent Light Technologies, Inc. | 1994-03-10 |
| K931546 | END-IRRIGATING ENDOILLUMINATOR | Infinitech, Inc. | 1994-02-09 |
| K922820 | WOODBINE XT350, XENON ARC LIGHT SOURCE | Woodbine Ptical Corp. | 1992-09-02 |
| K922544 | MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE | Kirschner Medical Corp. | 1992-08-07 |
| K921646 | NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON | Nextec Corp. | 1992-05-13 |
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| 10381780168133 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-09 |
| 10381780168119 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-09 |
| 10381780167877 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-09 |
| 10381780168461 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-09 |
| 10381780168478 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-09 |
| 10381780167952 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-09 |
| 10381780167921 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-09 |
| 10381780167983 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168232 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168010 | UltraLite® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168225 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168034 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168850 | UltraLite® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168072 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168867 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168836 | UltraLite® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780168843 | UltraLite® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780168065 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780168126 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780168027 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780168003 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780167990 | UltraLite® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780167976 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780167945 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780167938 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780167914 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-31 |
| 10381780167907 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-08-31 |
| 10381780251231 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-23 |
| 10381780251248 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-23 |